Improvement in quality standards of sodium oleate for pharmaceutical excipients

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Author:  YAN Cuixia ¹ Lyu Jing ¹ HU Chuanmei ¹ SHAO Hong ¹ ZHENG Luxia ¹ CHEN Lei ²

Affiliation: 1. Shanghai Institute for Food and Drug Control, National Medical Products Administration Key Laboratory of Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China 2. Chinese Pharmacopoeia Commission, Beijing 100061, China

Keywords: Sodium oleate Fatty acid composition Content determination Key quality attributes Quality standards Pharmaceutical excipients

DOI: 10.12173/j.issn.2097-4922.202409076

Reference: YAN Cuixia, Lyu Jing, HU Chuanmei, SHAO Hong, ZHENG Luxia, CHEN Lei. Improvement in quality standards of sodium oleate for pharmaceutical excipients[J]. Yaoxue QianYan Zazhi, 2025, 29(2): 210-217. DOI: 10.12173/j.issn.2097-4922.202409076.[Article in Chinese]  Copied

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Abstract

Objective To improve the quality standard of sodium oleate in the Chinese Pharmacopoeia (2020 Edition) Volume Four.

Methods The domestic and international pharmacopoeia standards were compared, the differences in the two items of fatty acid composition and content determination between domestic and international pharmacopoeia standards were focused on, the current national standard for fatty acid composition was examined, and HPLC for its content determination was established.

Results Based on the experimental results, the items of fatty acid composition and content determination in the current national pharmacopoeia standards had been revised and improved. The HPLC showed a good linear relationship for the determination of sodium oleate in the range of 0.30 to 1.82 mg/mL (r=0.999 5). The average spiked recovery rate was 100.5%, and the RSD was 1.1% (n=9). The content of sodium oleate in 15 batches of samples ranged from 60.4% to 101.2%.

Conclusion This study has improved and perfected the quality standards of sodium oleate from the aspects of safety and standardization, with the aim of providing a more accurate and reliable quality control standard for the industry.

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